Diagnostic Imaging Service Providers Must Comply With the Pennsylvania Patient Test Result Information Act

Effective December 23, 2018, pursuant to the Pennsylvania Patient Test Result Information Act (the “Act”), any entity performing a diagnostic imaging service (i.e., a medical imaging test performed on a patient that is intended to diagnose the presence or absence of a disease, including, but not limited to, a malignancy) must directly notify the patient or patient’s designee when, in the judgment of the entity performing the diagnostic imaging service, a significant abnormality may exist. A significant abnormality is a finding by a diagnostic imaging service of an abnormality or anomaly which would cause a reasonably prudent person to seek additional or follow-up medical care within three months.

The notice that is sent to the patient or patient’s designee must include the following:

• the name of the ordering health care practitioner;
• the date the test was performed;
• the date the results were sent to the ordering health care practitioner;
• the contact information necessary for the patient to obtain a full report; and
• the following statements:
  • You are receiving this notice as a result of a determination by your diagnostic imaging service that further discussions of your test results are warranted and would be beneficial to you.
  • The complete results of your test or tests have been or will be sent to the health care practitioner that ordered the test or tests. It is recommended that you contact your health care practitioner to discuss your results as soon as possible.

The notice may be provided directly to the patient at the time of service, so long as the patient acknowledges the receipt of the results and signs the patient’s medical record accordingly. Otherwise, the notice must be sent no later than 20 days after the date the results were sent to the ordering health care practitioner. The notice must be provided to the patient or patient’s designee in a manner deemed acceptable by the patient or the patient’s designee and may be:

• mailed in a properly addressed and stamped letter through the United States Postal Service;
• sent electronically by e-mail;
• sent by automatic alert from an electronic medical record system that the notice has been posted to the patient’s electronic medical record that is presently viewable; or
• sent by facsimile.

The notice is not required to be sent in relation to routine obstetrical ultrasounds used to monitor the development of a fetus, diagnostic imaging services performed on a patient who is being treated on an inpatient basis or in an emergency room, or diagnostic radiographs (i.e., an x-ray). Additionally, if the results are provided to the patient or patient’s designee by the health care practitioner at the time of the test, then the entity is not required to provide the patient or patient’s designee with the notice.

It is unclear what the consequences of violating the Act will be as the Act does not provide for any penalties for failure to comply. However, pursuant to the Act, the Pennsylvania Department of Health (“DOH”) must conduct compliance reviews as part of the inspection performed by DOH or an accrediting organization. Additionally, DOH must establish a complaint procedure, which will be made available on DOH’s publicly accessible website, and investigate complaints filed relating to the requirements of the Act.

All entities providing diagnostic imaging services should have a system in place no later than December 23, 2018, in order to provide the required notice to patients and their designees, as applicable. While we understand that DOH has indicated it will delay the issuing of sanctions for noncompliance with the Act, the Act still takes effect on December 23, 2018. Therefore, diagnostic imaging service providers must still comply with the Act even if DOH delays the issuing of sanctions. We will provide further updates on the Act if DOH releases any notices or guidance.

Please feel free to contact any member of our Health Law Department should you have any questions or need additional information regarding this health care alert.

This News Alert has been prepared for informational purposes only and should not be construed as, and does not constitute, legal advice on any specific matter. For more information, please see the disclaimer.